BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX

    MDR report key: 1062731 · Received June 17, 2008

    Report

    Report Number
    1820334-2008-00305
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA PROCEDURE IN 2007. ONE FLEX MAIN BODY, THREE ILIAC LEG GRAFTS, AND ONE MAIN BODY EXTENSION (USED IN THE ILIAC) WERE PLACED. FOLLOW-UP CT'S INDICATED DISTAL TYPE I ENDOLEAKS ON BOTH SIDES. IN 2008, THE PHYSICIAN EMBOLIZED THE HYPOGASTRIC ARTERY ON THE PT'S LEFT SIDE AND PLACED AN ADDITIONAL ILIAC LEG GRAFT TO EXTEND INTO THE EXTERNAL ILIAC ARTERY (SEE 1820334-2008-00304). ON THE PT'S RIGHT SIDE, TWO ADDITIONAL SEAL. A COMPLETION ANGIOGRAM INDICATED THAT BOTH ENDOLEAKS WERE RESOLVED. PT WAS FINE AND ENDOLEAKS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1730159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention